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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL

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LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 1010002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hernia (2240); Obstruction/Occlusion (2422)
Event Date 12/09/2015
Event Type  Injury  
Manufacturer Narrative
The internal investigation into strattice lot s11301 included a review of the reported information, review of the device history records and review of the complaint history records. The device was not returned to lifecell for evaluation. Investigation results revealed no remarkable findings with no similar complaints reported against the lot and no related deviations or nonconformances revealed during processing. The lot was terminally sterilized within the process parameters and met all qc release criteria. To date, of the 196 devices released to finished goods for lot s11301, 186 have been distributed. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
It was reported that a (b)(6) year old male underwent a ventral/umbilical hernia repair on (b)(6) 2013 by dr. (b)(6). The patient was implanted with strattice lot s11301-041. Two years after the surgery, the patient returned to the hospital on or about (b)(6) 2015 and was diagnosed with a partial small bowel obstruction. The patient had a release of partial small bowel obstruction, repair of recurrent ventral/umbilical hernia and removal of old mesh at (b)(6) hospital performed by dr. (b)(6). The patient was implanted with another piece of strattice, lot sp100295-142. After surgery, the patient returned to the hospital on (b)(6) 2016 and was diagnosed with small bowel obstruction. On (b)(6) 2016, the patient had a release of small bowel obstruction, release of internal hernia and excision of strattice mesh a medical west hospital. This record is associated with the first reported lot, s11301-041.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer (Section G)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12161051
MDR Text Key265174086
Report Number1000306051-2021-03025
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1010002
Device Lot NumberS11301
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/13/2021 Patient Sequence Number: 1
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